Canada – Guidance : Nitrosamine impurities in medications
This guidance represents Health Canada's current thinking and recommendations on issues related to N-nitrosamine impurities (nitrosamine impurities or nitrosamines). This guidance may be subject to...
USA – FDA issues draft guidance on decentralized clinical trials
In a newly released draft guidance, the US Food and Drug Administration (FDA) is proposing recommendations on conducting decentralized clinical trials (DCTs) of drugs,...
Europe – GSK’s RSV vaccine candidate recommended by CHMP for older adults
There are currently no vaccines available to help protect older adults from RSV, a common contagious virus characterised by several mild, cold-like symptoms. Although...
Europe – European Health Union: Commission proposes pharmaceuticals reform for more accessible, affordable and...
Today, the Commission is proposing to revise the EU's pharmaceutical legislation - the largest reform in over 20 years - to make it more agile, flexible,...
UK – NICE approval for Janssen’s Darzalex combination
Recommendation concerns routine use across the NHS as therapy for multiple myeloma
The Janssen Pharmaceutical Companies of Johnson & Johnson have announced that the National...
UK – Kite’s CAR-T therapies recommended by NICE for certain blood cancers
The treatments, both given as one-off infusions, have been specifically recommended for use within the Cancer Drugs Fund (CDF), which pays for cancer treatments...
USA – FDA issues final guidance on nicotine replacement therapy
The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) on Monday issued a final guidance to assist sponsors interested...
USA – MedCon: TAP pilot off the ground four devices enrolled
The US Food and Drug Administration (FDA) has enrolled the first four devices in its Total Product Life Cycle Advisory Program (TAP) pilot, while...
USA – FDA officials offer CMC advice for gene therapies at OTP town hall
Officials from the US Food and Drug Administration’s (FDA) Office of Therapeutic Products (OTP) within the Center for Biologics Evaluation and Research (CBER) urged...
UK – Janssen and AbbVie’s Imbruvica combination recommended by NICE for leukaemia
CLL is the common type of leukaemia in adults, with around 3,800 people in the UK diagnosed with the disease each year.
While patient outcomes...
